Engaging the public

Overview

Patients and members of the public are becoming increasingly involved in the design and delivery of health care research. This type of involvement means research is carried out “with” patients and members of the public, rather than them being “participants” in a research project.

INVOLVE, the UK's national body for patient and public involvement, recommends that patients and members of the public should be involved in all stages of a research project. This can help to increase the relevance of research, improve the quality of research, and help to disseminate the findings of the research to a broad audience (including patients and members of the public) in a more meaningful way. The following brief video helps demonstrate how patients and the public can become involved in research.

Although IPD meta-analyses are complex in terms of their methodology, there is still a role for patient and public involvement and engagement across all of its stages (shown in the figure below).

A case example of how this can be achieved can be found here:

Case study

Embedding Patient and Public Involvement and Engagement (PPIE) in an IPD Meta-analysis: A Case Example

Subgrouping and TargetEd Exercise pRogrammes for knee and hip OsteoArthritis (STEER OA): a systematic review update and individual participant data meta-analysis

1. Study overview

Introduction: Knee and hip osteoarthritis (OA) is a leading cause of disability worldwide. Therapeutic exercise is a recommended core treatment for people with knee and hip OA, however, the observed effect sizes for reducing pain and improving physical function are small to moderate. This may be due to insufficient targeting of exercise to subgroups of people who are most likely to respond and/or sub-optimal content of exercise programmes.

Aims:

1. Identify subgroups of people with knee and hip OA that do/ do not respond to therapeutic exercise and to different types of exercise (moderators of the effect of exercise)
2. Identify mediators of the effect of therapeutic exercise for reducing pain and improving physical function. This will enable optimal targeting and refining the content of future exercise interventions.

Methods and analysis: Systematic review and individual participant data meta-analyses. A previous comprehensive systematic review will be updated to identify randomised controlled trials that compare the effects of therapeutic exercise for people with knee and hip OA on pain and physical function to a non-exercise control. Lead authors of eligible trials will be invited to share individual participant data. Trial-level and participant-level characteristics (for baseline variables and outcomes) of included studies will be summarised. Meta-analyses will use a two-stage approach, where effect estimates are obtained for each trial and then synthesised using a random effects model (to account for heterogeneity). All analyses will be on an intention-to-treat principle and all summary meta-analysis estimates will be reported as standardised mean differences with 95% CI.

Ethics and dissemination:

Research ethical or governance approval is exempt as no new data are being collected and no identifiable participant information will be shared. Findings will be disseminated via national and international conferences, publication in peer-reviewed journals and summaries posted on websites accessed by the public and clinicians.

PROSPERO registration: CRD42017054049.

2. PPIE involvement over the course of the study

a) Pre-funding workshop

A workshop was convened with four patient representatives with experience of OA and therapeutic exercise. Ahead of the workshop, patient representatives were sent a lay summary describing the study, and a PPIE support worker attended the meeting, to offer support. At the workshop an overview of the study was provided and the following points were discussed:

1. Is this an important topic?
Patient representatives highlighted that the most important aspect of the study was to identify how to target the right ‘kind’ of exercise to specific subgroups, rather than to use exercise or not (thus potentially depriving some patients of access to any exercise).

2. What are the most important outcome measures?
Pain and function were thought to be the most important outcome measures.

3. Are we exploring response to exercise in the right type of patient subgroups?
Patient representatives identified several potential subgroups to explore in the IPD meta-analysis. They also identified subgroups that were deemed of little importance.

4. Are we exploring response to the right ‘kinds’ of exercise?
RUG members highlighted the importance of an individualised, holistic exercise programme versus a standardised exercise programme, and group versus individual exercise. 

5. Are our plans for PPIE involvement adequate?
Our plans for PPIE involvement over the course of the study were discussed and agreed to be useful and representative of the INVOLVE framework. As all patient representatives were keen to remain involved in the study, they requested forming a ‘PPIE working group’, acting as the first point of call for all PPIE activity related to this study.

6. How can we best disseminate the findings to a wide audience?
How best to disseminate the findings of the study to a wide audience was discussed and agreed, with patient representatives keen to become involved in this activity.

b) Post funding face-to-face collaborator meeting

Post funding a meeting was held with potential collaborators (i.e. trial principal investigators who had agreed in principle to share their trial IPD) and our PPIE working group. At the meeting the final protocol for the study was agreed and all potential subgroups moderating the effect of exercise were discussed and listed (n=40 potential subgroups (moderators) were identified in total). The protocol was published, with our PPIE working group listed as coauthors. 

c) Moderator ranking exercise

All collaborators and our PPIE working group (who contributed to the STEER OA protocol and were named co-authors on the protocol manuscript) were invited to participate in a moderator ranking exercise, conducted remotely.

Participants were presented with the list of 40 potential subgroups (moderators) that was initially generated at the post funding collaborator meeting. Participants were asked to highlight the 10 most important moderators of therapeutic exercise for knee/ hip OA. Frequency counts were completed to determine the total number of times a moderator was rated as being within the top 10. The 10 most frequently rated subgroups were then selected for analysis within the STEER OA IPD-meta-analyses.

The results of the moderator ranking exercise were presented at an international conference. The PPIE working group were named co-authors on this submission.

d) Interpretation of study findings

The STEER OA IPD meta-analysis is currently ongoing. Provisional results will be presented to the PPIE working group to gain insight into their thoughts about the key findings and what the research and clinical implications of the findings are.

e) Dissemination of study findings

• The PPIE working group will be involved in dissemination activities, including:
• Jointly written lay summaries being posted on the Keele University website and in local healthcare settings
• Presenting the results on local radio stations (e.g. Radio Stoke) and at local community healthcare groups (e.g. ‘Help you Heart’ group based in Nantwich, Cheshire)
• Jointly written articles for local and national magazines and newspapers

Members of our PPIE working group will be named co-authors on all outputs from the study.

Glossary

Systematic review:	A type of literature review that uses systematic methods to identify and then quantitatively and/or qualitatively synthesize findings from multiple independent studies that addressed a particular research question or collected relevant data regarding that question. They can be used to bring the results of similar studies together and assess the quality of all the evidence, to provide a summary of existing evidence.
Meta-analysis:	A quantitative summary of the results from multiple independent studies in order to estimate an overall effect. Often times, a meta-analysis is conducted using research studies identified in a systematic review.
IPD:	An acronym that stands for “individual patient data” or “individual participant data.” This refers to information recorded for each individual patient/participant from each study (e.g., their age, gender, medical conditions, etc.) being available for analysis.
IPD meta-analysis:	A meta-analysis that uses the combined set of “IPD” from relevant research studies on a particular research question (as opposed to combining the summary results from each study).
Moderator:	A variable that affects the direction and/or strength of the relationship between two other variables. For instance, if treatment X for disease “Y” works better for women than for men, then sex “moderates” the effect of treatment X. In statistical terms, this is referred to as an “interaction.” Alternative terms include “effect modification,” “prediction of treatment,” and “synergy.”
Mediator:	An intermediary or “middleman” variable that explains the relationship between 2 other variables. The first variable influences the mediator, which then influences the second variable. For example, the effect of school grades on happiness might be mediated by self-esteem. Mediators are often investigated as part of causal inference studies, or to identify potential targets for treatment.

Useful resources

Useful resources for learning more about how to engage patients and the public in research:

• NIHR INVOLVE
• Keele's PPIE useful resources